A Pilot Study of Intratumorally and Intraparenchymally Administered OS2966 using Convection-enhanced Delivery in Patients with Recurrent/Progressive High-grade Glioma Undergoing a Clinically-indicated Surgical Resection
The primary goal of this Phase 1 study is to determine if a new investigational drug, OS2966, when delivered directly to the brain of adult participants with recurrent/progressive high-grade glioma (HGG) is safe and well tolerated.
6.1. Primary Objective -To determine the safety and tolerability of OS2966 when delivered both intratumorally (to the bulk, contrast-enhancing tumor) and intraparenchymally (to the surrounding nonenhancing tumor-infiltrated brain) by CED using the ICMC and real-time imaging in patients with recurrent/progressive HGG. -To determine the optimal biological dose (OBD) of OS2966 when delivered intratumorally and intraparenchymally by CED. 6.2. Secondary Objectives Secondary objectives are as follows: - To determine the optimal CED infusion parameters with use of the ICMC, including infusion rate and duration, to maximize the Vd of OS2966 in the brain. - To determine if OS2966 reaches the systemic circulation after direct delivery to the brain. - To assess the preliminary efficacy of OS2966 when delivered directly to the tumor-infiltrated brain by CED using the ICMC. 6.3. Exploratory Objectives - To further characterize the pharmacokinetics (PK) and to characterize the pharmacodynamic (PD) effects of OS2966 after intratumoral administration. - To assess the following additional safety parameters: - AEs by system organ class (SOC), severity, and seriousness - Clinical laboratory assessments, including hematology, coagulation, chemistry, immunogenicity (anti-drug antibodies [ADAs]), as well as proportions of each that are out-of-normal range - Vital signs, including blood pressure (BP), heart rate (HR), and respiratory rate (RR) - 12-lead ECG, characterized as normal or abnormal - Physical examination by system and characterized as normal or abnormal - Karnofsky Performance Status (KPS) scores 6.4. Evaluation of Objectives Study objectives will be evaluated throughout the study as defined in Table 2.
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